Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bone Sarcoma
- Metastatic Bone Tumor
- Sarcoma
- Soft Tissue Sarcoma
- Unresectable Soft Tissue Sarcoma
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary objectives of this pilot study are to assess the feasibility of pharmacokinetically-guided, patient-individualized dosing and to obtain preliminary evidence of anti-tumor activity of intravenous ascorbate in combination with gemcitabine to inform a subsequent Phase II trial. Soft tissue ...
The primary objectives of this pilot study are to assess the feasibility of pharmacokinetically-guided, patient-individualized dosing and to obtain preliminary evidence of anti-tumor activity of intravenous ascorbate in combination with gemcitabine to inform a subsequent Phase II trial. Soft tissue and bone sarcomas will be studied as different cohorts given the differences in biology and historical responses to single agent gemcitabine in these disease types. As such, 10 evaluable patients per disease cohort will be included.
Tracking Information
- NCT #
- NCT04634227
- Collaborators
- University of Iowa Adolescent and Young Adult (AYA) Cancer Program
- St. Baldrick's Foundation
- University of Iowa
- Investigators
- Principal Investigator: Varun Monga, MD University of Iowa Hospitals & Clinics
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